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The purpose of this study is to evaluate the efficacy of APSTZD compared to one active drug and placebo in insomnia treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| APSTZD 1 | Experimental | 5 oral tablets, once a day, before bedtime, for 6 weeks. |
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| APSTZD 2 | Experimental | 5 oral tablets, once a day, before bedtime, for 6 weeks. |
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| APSTZD 3 | Experimental | 5 oral tablets, once a day, before bedtime, for 6 weeks. |
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| APSTZD 4 | Experimental | 5 oral tablets, once a day, before bedtime, for 6 weeks. |
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| Stilnox CR® | Active Comparator | 5 oral tablets, once a day, before bedtime, for 6 weeks. |
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| Placebo | Placebo Comparator | 5 oral tablets, once a day, before bedtime, for 6 weeks. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| APSTZD 1 | Drug | APSTZD + placebo test 2 + placebo test 3 + placebo test 4 + comparator placebo 1 |
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| Measure | Description | Time Frame |
|---|---|---|
| Reduction in WASO 6h (Wake After Sleep Onset) assessed by polysomnography | Change from baseline after 2 weeks of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events incidence and classification | Through study completion, up to 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fernanda Martinez Scalzaretto | Contact | +551156448200 | fernanda.martinez@apsen.com.br |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UNIFAG - Casa Nossa Senhora da PAZ -ASF | Bragança Paulista | São Paulo | 12916-900 | Brazil |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| APSTZD 2 | Drug | APSTZD + placebo test 1 + placebo test 3 + placebo test 4 + comparator placebo 1 |
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| APSTZD 3 | Drug | APSTZD + placebo test 1 + placebo test 2 + placebo test 4 + comparator placebo 1 |
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| APSTZD 4 | Drug | APSTZD + placebo test 1 + placebo test 2 + placebo test 3 + comparator placebo 1 |
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| Stilnox CR® | Drug | Stilnox CR® + placebo test 1 + placebo test 2 + placebo test 3 + placebo test 4 |
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| Placebo | Drug | placebo test 1 + placebo test 2 + placebo test 3 + placebo test 4 + comparator 1 |
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| D001523 |
| Mental Disorders |